Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-601D-1519 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of infection from non-sterile equipment, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling the NA-601D-1519 Aspiration Needle. This medical device is used with endoscopes to collect cells or tissue specimens in the respiratory organs. The recall affects 260,395 units in the United States, which were distributed nationwide.
The recall was initiated after inspections confirmed that a small percentage of sterile packages have inadequate package seals, specifically partial heat seals. The use of non-sterile equipment may result in patients developing infections.
Healthcare facilities and consumers should stop using the affected devices immediately. The affected lots are identified by the following codes: 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK.
The recalled product
- Product
- NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
- Manufacturer
- Aomori Olympus Co., Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 01K
- 02K
- 03K
- 04K
- 05K
- 06K
- 07K
- 08K
- 09K
- 0XK
- 98K
- 99K
- 9XK
- 9YK
- 9ZK
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 111 recalled by Aomori Olympus Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 111 products in this recall →Related recalls
Same manufacturer · Aomori Olympus Co., Ltd.
See all →- HighReusable Endoscopy Distal Attachments Recalled for Excessive DEHP Levels
FDA (Devices) · 2023-09-13
- HighOlympus Distal Attachment Recalled for Phthalate Exceeding Permissible Levels
FDA (Devices) · 2023-09-13
- HighAomori Olympus Recalls KD-612U Electrosurgical Snare Due to Seal Defects
FDA (Devices) · 2021-02-17
- HighAomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
FDA (Devices) · 2021-02-17
- HighAomori Olympus Recalls 22G EZSHOT Aspiration Needles Due to Seal Defects
FDA (Devices) · 2021-02-17
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateOlympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance
FDA (Devices) · 2023-05-31
- HighFifteen millimetre snares recalled over holes compromising package sterility
FDA (Devices) · 2025-11-19
- ModerateViziShot 2 Aspiration Needle recalled for manufacturing angle defect
FDA (Devices) · 2023-05-31
- HighElectrosurgical snares recalled over small holes compromising package sterility
FDA (Devices) · 2025-11-19
- SevereCustomed Recalls Ophthalmic Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- HighBiopsy Needle Recall Due to Compromised Sterility Assurance
FDA (Devices) · 2021-09-29